Duns Number:793169512
Device Description: CR SEMI-FIN PLATE PAN 15X30CM
Catalog Number
8427965
Brand Name
CS 7400
Version/Model Number
CS 7400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUH
Product Code Name
System,x-ray,extraoral source,digital
Public Device Record Key
7eb54abd-5b85-4610-9320-3a9653c95aaa
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
60889978427963
Quantity per Package
20
Contains DI Package
40889978427969
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 688 |